GMP Biosimilars Articles

The subject of biosimilars is currently a topic of great interest and discussion within the pharmaceutical industry, and will continue to be as certain innovator products reach patent expiration over the next several years. Key in the evaluation of biosimilars is the required demonstration that the biosimilar provides properties comparable to the biologic in relation to its safety, purity and potency.

PPD has extensive experience and expertise in the evaluation of biological products and biosimilars, and our scientists have shared their experience and findings on this topic at recent industry conferences. The presentations available for viewing here explore comparisons of biosimilar products across manufacturers, applying both physiochemical and functional analysis techniques.

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